COSY
- Primary DI
- 04047844101452
- Brand
- COSY
- Company
- SIGNUS Medizintechnik GmbH
- Model
- Revision occipital screw
- Catalog number
- CA0100-50006/S
- Device description
- The COSY Cervicothoracic Occipital Rod-Screw is a multiple component, posterior spinal fixations system which consists of solid screws, cannulated screws, standard tulips, angulated tulips, curved rods, straight rods, hybrid rods, parallel connectors, inline connectors, occipital plates, occipital bone screws, hooks, and offset connectors. All implants, except of variations of the rods, are available in Ti-6AL-4V ELI per ASTM F136. Rods are available in Ti-6AL-4V ELI per ASTM F136 or Co-Cr28-Mo6 per ASTM F1537. The pedicle screws consist of a tulip and a pedicle screw shaft. The shaft has aprominent thread, to provide anchorage of the screw in the pedicle section of the vertebrae. Each tulip is securely attached to the rod via a set screw. The shafts of the pedicle screws are provided in different lengths, diameters, fully or partially threaded, and with a symmetric or asymmetric angulation to provided adaptability to the patient’s anatomy. The rods can be shortened on site by the surgeon. The occipital plate is available with four or five holes and areas to be bent for better fixation to the occipital part of the skull. The plate is fixed via bone screws and as two gliding tulips to provided anchoring of the rod. The gliding tulips are constructed similar to the tulips of the pedicle screws in the area of the rod- set screw -tulip intersection.
- Published
- 2023-03-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K220658 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04047844101445 | Package | GS1 | 2 | In Commercial Distribution |
| 04047844101452 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04047844101445 | 04047844101445 | 4047844101445 |
| 04047844101452 | 04047844101452 | 4047844101452 |
GMDN Terms#
| Term | Definition |
|---|---|
| Bone-screw internal spinal fixation system, sterile | An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 0 Degrees Celsius | 35 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +49602391660 | info@signus.com |
Regulatory Flags#
- DUNS number
- 344203948
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04047844129418 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-95120 | 2026-07-13 |
| 04047844129425 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-45025 | 2026-07-13 |
| 04047844129432 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-45030 | 2026-07-13 |
| 04047844129449 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-45035 | 2026-07-13 |
| 04047844129456 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-45040 | 2026-07-13 |
| 04047844129463 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-45045 | 2026-07-13 |
| 04047844129470 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-45050 | 2026-07-13 |
| 04047844129487 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-45055 | 2026-07-13 |
| 04047844129494 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-45060 | 2026-07-13 |
| 04047844129500 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-55025 | 2026-07-13 |
| 04047844129517 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-55030 | 2026-07-13 |
| 04047844129524 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-55035 | 2026-07-13 |
| 04047844129531 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-55040 | 2026-07-13 |
| 04047844129548 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-55045 | 2026-07-13 |
| 04047844129555 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-55050 | 2026-07-13 |
| 04047844129562 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-55055 | 2026-07-13 |
| 04047844129579 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-55060 | 2026-07-13 |
| 04047844129586 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-65025 | 2026-07-13 |
| 04047844129593 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-65030 | 2026-07-13 |
| 04047844129609 | DIPLOMAT FT | Pedicle screw w/o tulip, cannulated, polyaxial | AB0222-65035 | 2026-07-13 |
Other Devices Sharing Product Codes#
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|---|---|---|---|---|
| 00199150015832 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015832 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015849 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015849 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015856 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015856 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015863 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015863 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015870 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015870 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015887 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015887 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015894 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015894 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015900 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015900 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015917 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015917 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015924 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015924 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015931 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015931 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015948 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015948 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015955 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015955 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015962 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |
| 00199150015962 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015986 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 2026-07-16 |
| 00199150015986 | INFINITY™ Occipitocervical Upper Thoracic System | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 2026-07-16 |